BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7085140 · Received December 5, 2017

    Report

    Report Number
    1710034-2017-00350
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    February 8, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    00382903673247
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5162965.CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 23 G X .75 IN. BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING BEGAN TO SQUIRT BLOOD OUT OF ITS PLASTIC TUBING UPON PUTTING ON A VACUTAINER TUBE. NO MEDICAL INTERVENTION/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863267 BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5162965 00382903673247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other